降糖类中药制剂中添加化学药品的检测方法研究  

Study on the Method for Examining of the Chemical Medicine in Traditional Chinese Medicinal Antidiabetic Preparations

作　　者：刘惠军[1] 付萍萍[1] 刘敏芳[1] 陈维壹 董秋香[1] 张月寒[1] 赵志伟[1] 孙志强[1] 

机构地区：[1]保定市药品检验所,河北保定071051

出　　处：《中国现代应用药学》2008年第6期525-527,共3页Chinese Journal of Modern Applied Pharmacy

基　　金：河北省科学技术研究与发展指导计划课题(06276419)

摘　　要：目的建立降糖类中药制剂中同时检测盐酸二甲双胍等6种化学药品的HPLC。方法采用Hypersil BDS C18色谱柱(200 mm×4.6 mm,5μm),以离子对试液(取庚烷磺酸钠0.5 g,加三乙胺1.4 mL,加水至1 000 mL,用磷酸调节pH值至3.5±0.05)-甲醇为流动相,梯度洗脱;流速为1.0 mL.m in-1,检测波长为233 nm。结果6种化学药品均能得到较好的分离,且在一定的进样量范围内呈现良好的线性。结论本法快速、简便,能同时对6种化学药品进行定性、定量分析,可用于鉴定降糖中药制剂中是否添加化学药品。OBJECTIVE To establish an HPLC method with gradient operation for the examining of mefformin hydroehloride, phenformin hydrochlorid, glibenclamide, glipizide, gliclazide, gliquidone in traditional Chinese medicinal antidiabetic preparations. METHODS Chromatographic assay was performed on a column of hypersil C18 （ 200 mm× 4. 6 mm, 5 μm ） , using sodium heptanesulfonate solution （ contain 0.5 g sodium heptanesulfonate and 1.4 mL triethylamine in 1000 mL of water, adjusted to pH 3.5 ＋ 0.05 with H3 PO4 ） -methanol as the mobile phase with the flow rate of 1.0 mL · min^-1. The detective wavelength was set at 233 nm. RESULTS Six compositions could be well separated. And their calibration curves were good over the range of definite sampler. CONCLUSION The method is quick, convenient and can be used to analyze the quality and quantity for six chemical medicine. It can be employed to the examination of the chemical medicine in traditional Chinese medicinal antidiabetic preparations.

关 键 词：降糖类中药制剂 化学药品 高效液相色谱法 

分 类 号：R917.101[医药卫生—药物分析学] R927.11[医药卫生—药学]